Effectiveness of HabitWorks and Symptom Tracking for Anxiety and Depression

NCT07025486 | Completed

• 1 other identifier: 2022P001752
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

Our objective is to conduct a randomized controlled trial (RCT) that compares two digital interventions - Symptom Tracking and the HabitWorks app - in a sample of adults endorsing symptoms of anxiety or depression. We hope to obtain pilot data to support a fully powered RCT to test moderators:

1. 1.Target engagement (improvement in interpretation bias)
2. 2.Feasibility and acceptability of Symptom Tracking and HabitWorks and procedures for a general community sample
3. 3.Symptom and functioning measures

Conditions

Anxiety; Depression, Anxiety

Keywords

interpretation bias; digital mental health

Outcome Measures

Primary Outcomes (1)

• GAD-7

  self-report measure of general anxiety symptoms, completed online via RedCap

  From enrollment to the end of followup period at 8 weeks

Secondary Outcomes (1)

• Clinical Global Improvement Scale

  post-treatment (4 weeks after enrollment)

Study Arms (2)

HabitWorks + Symptom Tracking

EXPERIMENTAL

Use of HabitWorks app 3 times/week for 4 weeks + weekly symptom tracking

Behavioral: HabitWorks; Behavioral: Symptom TRacking

Symptom Tracking

ACTIVE COMPARATOR

Symptom Tracking 3 times per week for 4 weeks

Behavioral: Symptom TRacking

Interventions

HabitWorks BEHAVIORAL

Smartphone delivered interpretation bias exercises, symptom tracking

HabitWorks + Symptom Tracking

Symptom TRacking BEHAVIORAL

Self-assessment via symptom surveys

HabitWorks + Symptom Tracking; Symptom Tracking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 at the time of consent (19 in Nebraska, 21 in Puerto Rico based on age of consent)
• Current US resident
• Total score ≥ 3 on the Patient Health Questionnaire-2 (Kroenke et al., 2003) or Generalized Anxiety Disorder-2 (Spitzer et al., 2006), indicating at least mild depression and/or anxiety symptoms
• hour access to an iPhone smartphone
• ability to understand English

You may not qualify if:

• No current psychiatric symptoms that would prevent informed consent, understanding of research procedures, or ability to complete the study (e.g., active symptoms of psychosis, mania)
• No medical symptoms that would prevent informed consent, understanding of research procedures, or ability to complete the study (e.g., physical disability)

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: March 13, 2024
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: anticipated July 2025 with no end date
• Access Criteria: open science framework

Locations

US (1)